Interconnect for on-body analyte monitoring device

ABSTRACT

Disclosed herein are systems and methods for providing a compressible interconnect for allowing electrical communication between an electronics unit and an analyte sensor in an on-body analyte monitoring device. In other embodiments, systems and methods are provided for reducing the Z-height of an on-body analyte monitoring device by utilizing novel interconnects.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/674,439, filed Aug. 10, 2017, which is a continuation ofU.S. patent application Ser. No. 15/140,309, filed Apr. 27, 2016, nowU.S. Pat. No. 9,750,444, which is a continuation of U.S. patentapplication Ser. No. 12/895,015, filed Sep. 30, 2010, now U.S. Pat. No.9,351,669, which claims the benefit of U.S. Provisional Application No.61/247,516, filed Sep. 30, 2009, all of which are incorporated herein byreference in their entireties for all purposes.

FIELD OF THE INVENTION

The present invention relates to an analyte monitoring system. Moreparticularly, the present invention relates to apparatus forestablishing electrical communication between an analyte sensor and anelectronics unit in an on-body analyte monitoring device.

BACKGROUND OF THE INVENTION

The detection and/or monitoring of glucose levels or other analytes,such as lactate, oxygen, A1C, or the like, in certain individuals isvitally important to their health. For example, the monitoring ofglucose is particularly important to individuals with diabetes.Diabetics generally monitor glucose levels to determine if their glucoselevels are being maintained within a clinically safe range, and may alsouse this information to determine if and/or when insulin is needed toreduce glucose levels in their bodies or when additional glucose isneeded to raise the level of glucose in their bodies.

Growing clinical data demonstrates a strong correlation between thefrequency of glucose monitoring and glycemic control. Despite suchcorrelation, many individuals diagnosed with a diabetic condition do notmonitor their glucose levels as frequently as they should due to acombination of factors including convenience, testing discretion, painassociated with glucose testing, and cost.

Devices have been developed for the automatic monitoring of analyte(s),such as glucose, in bodily fluid such as in the blood stream or ininterstitial fluid (“ISF”), or other biological fluid. Some of theseanalyte measuring devices are configured so that at least a portion ofthe devices are positioned below a skin surface of a user, e.g., in ablood vessel or in the subcutaneous tissue of a user, so that themonitoring is accomplished in vivo.

With the continued development of analyte monitoring devices andsystems, there is a need for such analyte monitoring devices, systems,and methods, as well as for processes for manufacturing analytemonitoring devices and systems that are cost effective, convenient, andwith reduced pain, provide discreet monitoring to encourage frequentanalyte monitoring to improve glycemic control.

Typically, a glucose monitor consists of an analyte sensor that isimplanted in a patient and an electronics unit adapted to establishelectrical communication with the analyte sensor. The electricalcommunication may be accomplished utilizing a number of differentinterconnects. For example, some electronics units utilize pogo pins,polymer pins, solid pins, or springs as interconnects. However, each ofthese known interconnects has potential drawbacks. For example, pogopins are not durable, and moisture can seep into the spring mechanism,thereby degrading their performance. Similarly, polymer pins can degradeand wear after multiple cleanings Solid pins generally require extensivemodification of existing systems, leading to higher costs for thepatient. Spring connections are delicate, and may be prone to failureafter extended use. Therefore, there clearly exists a need for alow-cost, waterproof, flexible interconnect that allows for efficientand reliable electrical communication between an analyte sensor and anelectronics unit.

In other instances, a user may need to wear an on-body analytemonitoring device for an extended period of time. Generally, the on-bodymonitoring device includes a mounting unit housing an analyte sensor andan electronics unit. However, such devices can be bulky anduncomfortable due to the size and vertical height (“Z-height”) of theelectronics unit and the size of the mounting unit, which should besufficiently large to house the electronics unit. Therefore, thereexists a need for an on-body analyte monitoring device having astreamlined body and low profile (e.g., reduced Z-height) for a morecomfortable wear and patient compliance.

SUMMARY OF THE INVENTION

Generally, the present invention relates to an interconnect configuredto establish electrical communication between an analyte sensor and anelectronics unit. The analyte sensor, interconnect, and the electronicsunit define an on-body analyte monitoring device having a low profile.The on-body analyte monitoring device can be used with analytemonitoring system, such as for example, a continuous glucose monitoringsystem or analyte measurement system which provides analyte levels ondemand. An analyte monitoring system generally includes an on-bodyanalyte monitoring device and one or more receiver/display units.Optionally, the analyte monitoring system can further include a dataprocessing unit, such as for example a CPU. Thus, in one embodiment, theon-body analyte monitoring device comprises an analyte sensor formeasuring analyte levels, an electronics unit adapted to process thesignals relating to the analyte levels generated by the analyte sensor,and an interconnect adapted to establish electrical conductivity betweenthe electronics unit and the analyte sensor.

In one embodiment, the electronics unit includes a processor disposedwithin the body of the electronics unit. The processor can comprise anapplication specific integrated circuit (ASIC). In some embodiments, anelongate interconnect is coupled to the body of the electronics unit,such as for example the sidewall of the electronics unit proximate ananalyte sensor. In some embodiments, the elongate interconnect canextend laterally from the electronics unit so as to contact an analytesensor disposed adjacent the electronics unit.

The elongate interconnect comprises conductive material, such as, butnot limited to, conductive cables, such as ribbon cables. In someembodiments, the conductive material can be embedded or etched in aflexible material, such as a flexible strip of thermoplastic material.The flexible strip may be formed from any suitable thermoplasticmaterial. For example, the thermoplastic material includes polyimidessuch as Apical, Kapton, UPILEX, VTEC PI, Norton TH, polyester, mylar,and Kaptrex. However, in other embodiments, the conductive material canbe encapsulated in a flexible sheath.

In some embodiments, the elongate interconnect is coupled to theelectronics unit, for example, to a circuit board disposed in the bodyof the electronics unit, to establish electrical communication betweenthe electronics unit and interconnect. Additionally, the elongateinterconnect can establish electrical communication with an analytesensor. In some embodiments, the elongate interconnect can include aconductive material such as a conductive contact to contact or otherwisecouple to the analyte sensor, thereby establishing electricalcommunication between the interconnect and the analyte sensor. In someembodiments, the elongate interconnect is formed of a flexible materialsuch that the extended length of the interconnect can collapse orotherwise deform when the electronics unit is coupled to the analytesensor. Upon disengagement of the analyte sensor and the electronicsunit, the elongate interconnect can return to its non-collapsedconfiguration.

The analyte sensor, for example, in some embodiments, includes asubstrate having conductive material, such as one or more electrodes andone or more conductive contacts. In some embodiments, the conductivematerial comprises gold, which can be formed using ablation techniques(e.g., laser ablation). The analyte sensor can be configured to monitorglucose levels or any other analyte of interest, including drugs.

In some embodiments, the electronics unit may further comprise a sealdisposed proximate the elongate interconnect. The seal may be anindividual molded component made of low durometer silicone, rubber orsome other material TPE. In some embodiments, the interconnect extendsapproximately 1 mm beyond the face of the seal. When the electronicsunit is locked into position, the interconnect compresses and makescontact with the conductive pads on the sensor. The seal also compressesto form a barrier around the perimeter of the interconnect/sensorconnection. The interconnect may work without the seal, however onceliquid or dust got in, the interconnect/sensor interface may becompromised and fail.

In some embodiments, the seal includes an opening to permit directcontact of a conductive contact disposed on the interconnect to theanalyte sensor. In this manner, the analyte sensor and the electronicsunit can establish electrical conductivity via the closed circuitprovided by the interconnect.

In another aspect of the invention, an on-body analyte monitoring devicehaving a reduced vertical height is provided. In one embodiment, theinterconnect includes a top surface and a bottom surface adapted toengage, for example, interlock, with the body of the electronics unit.The interconnect includes conductive material, which establisheselectrical communication with and between both an analyte sensor and anelectronics unit. In some embodiments, the electronics unit may comprisea circuit board for interfacing with a conductive area of theinterconnect thereby establishing electrical communication between theinterconnect and the electronics unit. Thus, when interconnect isengaged to the electronics unit, the conductive material or areas of theinterconnect form a closed circuitry with the electronics unit and theanalyte sensor, thereby establishing electrical communication betweenthe analyte sensor and the electronics unit.

In some embodiments, the conductive material includes a conductive film,such as an anisotropic film or an elastomeric connector, such as aZebra® style connector. Alternatively, the first and second conductivematerial can include clips.

In one embodiment, the conductive surfaces can further include anadhesive for adhering the electronics unit and analyte sensor to theinterconnect. The adhesive can be a UV curable adhesive or any othersuitable adhesive. Other examples include a multi-adhesive system, suchas a silver loaded epoxy, which allows for the electronics unit andanalyte sensor to be adhered together while also placing the electronicsunit and analyte sensor in electrical communication.

The interconnect can also include a power source, such as a battery topower the electronics unit. In this manner, the electronics unit can beconfigured without its own internal power supply.

In some embodiments, the bottom surface of the interconnect includes anadhesive surface capable of bonding with human skin. Accordingly, theinterconnect can also serve as a mounting unit to adhere the on-bodydevice to a subject, such that a separate mounting unit component is notrequired.

In some embodiments, the interconnect is configured to engage theelectronics unit to define a two-component on-body monitoring device. Inother embodiments, the interconnect, sensor, and electronics unit areintegrated to define a single component on-body monitoring device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a block diagram of a data monitoring and managementsystem for practicing one or more embodiments of the present invention;

FIG. 1B illustrates a schematic diagram of the elements of FIG. 1A;

FIG. 2 illustrates a schematic view of an electronics unit according toone or more embodiments of the present invention;

FIG. 3 illustrates a schematic view of the elongate interconnect of theelectronics unit of FIG. 2 in a flat position;

FIG. 4 illustrates a schematic view of the electronics unit of FIG. 2when it is in contact with an analyte sensor;

FIGS. 5A-5D depict various elongate interconnects compatible with one ormore embodiments of the present invention;

FIG. 6 depicts a pictorial view of an analyte monitoring deviceaccording to another embodiment of the present invention;

FIG. 7A depicts a pictorial view of the analyte monitoring device ofFIG. 6 when it is disassembled;

FIG. 7B depicts a bottom view of the on-body analyte monitoring deviceof FIG. 7A;

FIG. 8 depicts the interconnect of FIG. 7B with the battery and analytesensor removed.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Before the present disclosure is described in detail, it is to beunderstood that this disclosure is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present disclosure will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the disclosure. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges as also encompassed within the disclosure, subject to anyspecifically excluded limit in the stated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present disclosure, the preferredmethods and materials are now described. All publications mentionedherein are incorporated herein by reference to disclose and describe themethods and/or materials in connection with which the publications arecited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.

Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

The figures shown herein are not necessarily drawn to scale, with somecomponents and features being exaggerated for clarity.

Generally, embodiments of the present disclosure relate to in vivomethods and devices for detecting at least one analyte such as glucosein body fluid. Accordingly, embodiments include in vivo analyte sensorsconfigured so that at least a portion of the sensor is positioned in thebody of a user (e.g., within the ISF), to obtain information about atleast one analyte of the body, e.g., transcutaneously positioned inuser's body. In certain embodiments, an in vivo analyte sensor iscoupled to an electronics unit that is maintained on the body of theuser such as on a skin surface, where such coupling provides on body, invivo analyte sensor electronics assemblies.

In certain embodiments, analyte information is communicated from a firstdevice such as an on body electronics unit to a second device which mayinclude user interface features, including a display, and/or the like.Information may be communicated from the first device to the seconddevice automatically and/or continuously when the analyte information isavailable, or may not be communicated automatically and/or continuously,but rather stored or logged in a memory of the first device.Accordingly, in many embodiments of the system, analyte informationderived by the sensor/on body electronics (for example, on bodyelectronics assembly) is made available in a user-usable or viewableform only when queried by the user such that the timing of datacommunication is selected by the user.

In this manner, analyte information is only provided or evident to auser (provided at a user interface device) when desired by the user eventhough an in vivo analyte sensor automatically and/or continuouslymonitors the analyte level in vivo, i.e., the sensor automaticallymonitors analyte such as glucose on a pre-defined time interval over itsusage life. For example, an analyte sensor may be positioned in vivo andcoupled to on body electronics for a given sensing period, e.g., about14 days. In certain embodiments, the sensor-derived analyte informationis automatically communicated from the sensor electronics assembly to aremote monitor device or display device for output to a user throughoutthe 14 day period according to a schedule programmed at the on bodyelectronics (e.g., about every 1 minute or about every 5 minutes orabout every 10 minutes, or the like). In certain embodiments,sensor-derived analyte information is only communicated from the sensorelectronics assembly to a remote monitor device or display device atuser-determined times, e.g., whenever a user decides to check analyteinformation. At such times, a communications system is activated, andsensor-derived information is then sent from the on body electronics tothe remote device or display device.

In still other embodiments, the information may be communicated from thefirst device to the second device automatically and/or continuously whenthe analyte information is available, and the second device stores orlogs the received information without presenting or outputting theinformation to the user. In such embodiments, the information isreceived by the second device from the first device when the informationbecomes available (e.g., when the sensor detects the analyte levelaccording to a time schedule). However, the received information isinitially stored in the second device and only output to a userinterface or an output component of the second device (e.g., display)upon detection of a request for the information on the second device.

Accordingly, in certain embodiments once a sensor electronics assemblyis placed on the body so that at least a portion of the in vivo sensoris in contact with bodily fluid such as ISF and the sensor iselectrically coupled to the electronics unit, sensor derived analyteinformation may be communicated from the on body electronics to adisplay device on-demand by powering on the display device (or it may becontinually powered), and executing a software algorithm stored in andaccessed from a memory of the display device, to generate one or morerequest commands, control signal or data packet to send to the on bodyelectronics. The software algorithm executed under, for example, thecontrol of the microprocessor or application specific integrated circuit(ASIC) of the display device may include routines to detect the positionof the on body electronics relative to the display device to initiatethe transmission of the generated request command, control signal and/ordata packet.

Display devices may also include programming stored in memory forexecution by one or more microprocessors and/or ASICs to generate andtransmit the one or more request command, control signal or data packetto send to the on body electronics in response to a user activation ofan input mechanism on the display device such as depressing a button onthe display device, triggering a soft button associated with the datacommunication function, and so on. The input mechanism may bealternatively or additionally provided on or in the on body electronicswhich may be configured for user activation. In certain embodiments,voice commands or audible signals may be used to prompt or instruct themicroprocessor or ASIC to execute the software routine(s) stored in thememory to generate and transmit the one or more request command, controlsignal or data packet to the on body device. In the embodiments that arevoice activated or responsive to voice commands or audible signals, onbody electronics and/or display device includes a microphone, a speaker,and processing routines stored in the respective memories of the on bodyelectronics and/or the display device to process the voice commandsand/or audible signals. In certain embodiments, positioning the on bodydevice and the display device within a predetermined distance (e.g.,close proximity) relative to each other initiates one or more softwareroutines stored in the memory of the display device to generate andtransmit a request command, control signal or data packet.

Different types and/or forms and/or amounts of information may be sentfor each on demand reading, including, but not limited to, one or moreof current analyte level information (i.e., real time or the mostrecently obtained analyte level information temporally corresponding tothe time the reading is initiated), rate of change of an analyte over apredetermined time period, rate of the rate of change of an analyte(acceleration in the rate of change), historical analyte informationcorresponding to analyte information obtained prior to a given readingand stored in memory of the assembly. Some or all of real time,historical, rate of change, rate of rate of change (such as accelerationor deceleration) information may be sent to a display device for a givenreading. In certain embodiments, the type and/or form and/or amount ofinformation sent to a display device may be preprogrammed and/orunchangeable (e.g., preset at manufacturing), or may not bepreprogrammed and/or unchangeable so that it may be selectable and/orchangeable in the field one or more times (e.g., by activating a switchof the system, etc.). Accordingly, in certain embodiments, for each ondemand reading, a display device will output a current (real time)sensor-derived analyte value (e.g., in numerical format), a current rateof analyte change (e.g., in the form of an analyte rate indicator suchas an arrow pointing in a direction to indicate the current rate), andanalyte trend history data based on sensor readings acquired by andstored in memory of on body electronics (e.g., in the form of agraphical trace). Additionally, the on skin or sensor temperaturereading or measurement associated with each on demand reading may becommunicated from the on body electronics to the display device. Thetemperature reading or measurement, however, may not be output ordisplayed on the display device, but rather, used in conjunction with asoftware routine executed by the display device to correct or compensatethe analyte measurement output to the user on the display device.

As described, embodiments include in vivo analyte sensors and on bodyelectronics that together provide body wearable sensor electronicsassemblies. In certain embodiments, in vivo analyte sensors are fullyintegrated with on body electronics (fixedly connected duringmanufacture), while in other embodiments they are separate butconnectable post manufacture (e.g., before, during or after sensorinsertion into a body). On body electronics may include an in vivoglucose sensor, electronics, battery, and antenna encased (except forthe sensor portion that is for in vivo positioning) in a waterproofhousing that includes or is attachable to an adhesive pad. In certainembodiments, the housing withstands immersion in about one meter ofwater for up to at least 30 minutes. In certain embodiments, the housingwithstands continuous underwater contact, e.g., for longer than about 30minutes, and continues to function properly according to its intendeduse, e.g., without water damage to the housing electronics where thehousing is suitable for water submersion.

Embodiments include sensor insertion devices, which also may be referredto herein as sensor delivery units, or the like. Insertion devices mayretain on body electronics assemblies completely in an interiorcompartment, i.e., an insertion device may be “pre-loaded” with on bodyelectronics assemblies during the manufacturing process (e.g., on bodyelectronics may be packaged in a sterile interior compartment of aninsertion device). In such embodiments, insertion devices may formsensor assembly packages (including sterile packages) for pre-use or newon body electronics assemblies, and insertion devices configured toapply on body electronics assemblies to recipient bodies.

Embodiments include portable handheld display devices, as separatedevices and spaced apart from an on body electronics assembly, thatcollect information from the assemblies and provide sensor derivedanalyte readings to users. Such devices may also be referred to asmeters, readers, monitors, receivers, human interface devices,companions, or the like. Certain embodiments may include an integratedin vitro analyte meter. In certain embodiments, display devices includeone or more wired or wireless communications ports such as USB, serial,parallel, or the like, configured to establish communication between adisplay device and another unit (e.g., on body electronics, power unitto recharge a battery, a PC, etc.). For example, a display devicecommunication port may enable charging a display device battery with arespective charging cable and/or data exchange between a display deviceand its compatible informatics software.

Compatible informatics software in certain embodiments include, forexample, but are not limited to, stand alone or network connectionenabled data management software program, resident or running on adisplay device, personal computer, a server terminal, for example, toperform data analysis, charting, data storage, data archiving and datacommunication as well as data synchronization. Informatics software incertain embodiments may also include software for executing fieldupgradable functions to upgrade firmware of a display device and/or onbody electronics unit to upgrade the resident software on the displaydevice and/or the on body electronics unit, e.g., with versions offirmware that include additional features and/or include software bugsor errors fixed, etc.

Embodiments may include a haptic feedback feature such as a vibrationmotor or the like, configured so that corresponding notifications (e.g.,a successful on-demand reading received at a display device), may bedelivered in the form of haptic feedback.

Embodiments include programming embedded on a computer readable medium,i.e., computer-based application software (may also be referred toherein as informatics software or programming or the like) thatprocesses analyte information obtained from the system and/or userself-reported data. Application software may be installed on a hostcomputer such as a mobile telephone, PC, an Internet-enabled humaninterface device such as an Internet-enabled phone, personal digitalassistant, or the like, by a display device or an on body electronicsunit. Informatics programming may transform data acquired and stored ona display device or on body unit for use by a user.

Embodiments of the subject disclosure are described primarily withrespect to glucose monitoring devices and systems, and methods ofglucose monitoring, for convenience only and such description is in noway intended to limit the scope of the disclosure. It is to beunderstood that the analyte monitoring system may be configured tomonitor a variety of analytes at the same time or at different times.

For example, analytes that may be monitored include, but are not limitedto, acetyl choline, amylase, bilirubin, cholesterol, chorionicgonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,fructosamine, glucose, glutamine, growth hormones, hormones, ketones,lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA,thyroid stimulating hormone, and troponin. The concentration of drugs,such as, for example, antibiotics (e.g., gentamicin, vancomycin, and thelike), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin,may also be monitored. In those embodiments that monitor more than oneanalyte, the analytes may be monitored at the same or different times,with a single sensor or with a plurality of sensors which may use thesame on body electronics (e.g., simultaneously) or with different onbody electronics.

As described in detail below, embodiments include devices, systems, kitsand/or methods to monitor one or more physiological parameters such as,for example, but not limited to, analyte levels, temperature levels,heart rate, user activity level, over a predetermined monitoring timeperiod. Also provided are methods of manufacturing. Predeterminedmonitoring time periods may be less than 1 hour, or may include about 1hour or more, e.g., about a few hours or more, e.g., about a few days ofmore, e.g., about 3 or more days, e.g., about 5 days or more, e.g.,about 7 days or more, e.g., about 10 days or more, e.g., about 14 daysor more, e.g., about several weeks, e.g., about 1 month or more. Incertain embodiments, after the expiration of the predeterminedmonitoring time period, one or more features of the system may beautomatically deactivated or disabled at the on body electronicsassembly and/or display device.

For example, a predetermined monitoring time period may begin withpositioning the sensor in vivo and in contact with a body fluid such asISF, and/or with the initiation (or powering on to full operationalmode) of the on body electronics. Initialization of on body electronicsmay be implemented with a command generated and transmitted by a displaydevice in response to the activation of a switch and/or by placing thedisplay device within a predetermined distance (e.g., close proximity)to the on body electronics, or by user manual activation of a switch onthe on body electronics unit, e.g., depressing a button, or suchactivation may be caused by the insertion device, e.g., as described inU.S. patent application Ser. No. 12/698,129, now U.S. Pat. No.9,402,544, and U.S. Provisional Application Nos. 61/238,646, 61/246,825,61/247,516, 61/249,535, 61/317,243, 61/345,562, and 61/361,374, thedisclosures of each of which are incorporated herein by reference forall purposes.

When initialized in response to a received command from a displaydevice, the on body electronics retrieves and executes from its memorysoftware routine to fully power on the components of the on bodyelectronics, effectively placing the on body electronics in fulloperational mode in response to receiving the activation command fromthe display device. For example, prior to the receipt of the commandfrom the display device, a portion of the components in the on bodyelectronics may be powered by its internal power supply such as abattery while another portion of the components in the on bodyelectronics may be in powered down or low power including no power,inactive mode, or all components may be in an inactive mode, powereddown mode. Upon receipt of the command, the remaining portion (or all)of the components of the on body electronics is switched to active,fully operational mode.

Embodiments of on body electronics may include one or more circuitboards with electronics including control logic implemented in ASIC,microprocessors, memory, and the like, and transcutaneously positionableanalyte sensors forming a single assembly. On body electronics may beconfigured to provide one or more signals or data packets associatedwith a monitored analyte level upon detection of a display device of theanalyte monitoring system within a predetermined proximity for a periodof time (for example, about 2 minutes, e.g., 1 minute or less, e.g.,about 30 seconds or less, e.g., about 10 seconds or less, e.g., about 5seconds or less, e.g., about 2 seconds or less) and/or until aconfirmation, such as an audible and/or visual and/or tactile (e.g.,vibratory) notification, is output on the display device indicatingsuccessful acquisition of the analyte related signal from the on bodyelectronics. A distinguishing notification may also be output forunsuccessful acquisition in certain embodiments.

In certain embodiments, the monitored analyte level may be correlatedand/or converted to glucose levels in blood or other fluids such as ISF.Such conversion may be accomplished with the on body electronics, but inmany embodiments will be accomplished with display device electronics.In certain embodiments, glucose level is derived from the monitoredanalyte level in the ISF.

Analyte sensors may be insertable into a vein, artery, or other portionof the body containing analyte. In certain embodiments, analyte sensorsmay be positioned in contact with ISF to detect the level of analyte,where the detected analyte level may be used to infer the user's glucoselevel in blood or interstitial tissue.

Embodiments include transcutaneous sensors and also wholly implantablesensors and wholly implantable assemblies in which a single assemblyincluding the analyte sensor and electronics are provided in a sealedhousing (e.g., hermetically sealed biocompatible housing) forimplantation in a user's body for monitoring one or more physiologicalparameters.

Embodiments of In Vivo Analyte Monitoring Systems

FIGS. 1A and 1B show an exemplary in vivo-based analyte monitoringsystem 100 in accordance with embodiments of the present disclosure. Asshown, in certain embodiments, analyte monitoring system 100 includes onbody electronics 110 electrically coupled to in vivo analyte sensor 101and attached to adhesive layer 140 for attachment on a skin surface onthe body of a user. On body electronics 110 includes on body housing119, that defines an interior compartment. Also shown in FIG. 1B isinsertion device 150 that, when operated, transcutaneously positions aportion of analyte sensor 101 through a skin surface and in fluidcontact with interstitial fluid, and positions on body electronics 110and adhesive layer 140 on a skin surface. In certain embodiments, onbody electronics 110, analyte sensor 101 and adhesive layer 140 aresealed within the housing of insertion device 150 before use, and incertain embodiments, adhesive layer 140 is also sealed within thehousing or itself provides a terminal seal of the insertion device 150.Devices, systems and methods that may be used with embodiments hereinare described, e.g., in U.S. patent application Ser. No. 12/698,129, nowU.S. Pat. No. 9,402,544, and U.S. Provisional Application Nos.61/238,646, 61/246,825, 61/247,516, 61/249,535, 61/317,243, 61/345,562,and 61/361,374, the disclosures of each of which are incorporated hereinby reference for all purposes.

Referring back to the FIG. 1B, analyte monitoring system 100 includesdisplay device 120 which includes a display 122 to output information tothe user, an input component 121 such as a button, actuator, a touchsensitive switch, a capacitive switch, pressure sensitive switch, jogwheel or the like, to input data or command to display device 120 orotherwise control the operation of display device 120. It is noted thatsome embodiments may include display-less devices or devices without anyuser interface components. These devices may be functionalized to storedata as a data logger and/or provide a conduit to transfer data from onbody electronics and/or a display-less device to another device and/orlocation. Embodiments will be described herein as display devices forexemplary purposes which are in no way intended to limit the embodimentsof the present disclosure. It will be apparent that display-less devicesmay also be used in certain embodiments.

In certain embodiments, on body electronics 110 may be configured tostore some or all of the monitored analyte related data received fromanalyte sensor 101 in a memory during the monitoring time period, andmaintain it in memory until the usage period ends. In such embodiments,stored data is retrieved from on body electronics 110 at the conclusionof the monitoring time period, for example, after removing analytesensor 101 from the user by detaching on body electronics 110 from theskin surface where it was positioned during the monitoring time period.In such data logging configurations, real time monitored analyte levelis not communicated to display device 120 during the monitoring periodor otherwise transmitted from on body electronics 110, but rather,retrieved from on body electronics 110 after the monitoring time period.

In certain embodiments, input component 121 of display device 120 mayinclude a microphone and display device 120 may include softwareconfigured to analyze audio input received from the microphone, suchthat functions and operation of the display device 120 may be controlledby voice commands. In certain embodiments, an output component ofdisplay device 120 includes a speaker for outputting information asaudible signals. Similar voice responsive components such as a speaker,microphone and software routines to generate, process and store voicedriven signals may be provided to on body electronics 110.

In certain embodiments, display 122 and input component 121 may beintegrated into a single component, for example a display that candetect the presence and location of a physical contact touch upon thedisplay such as a touch screen user interface. In such embodiments, theuser may control the operation of display device 120 by utilizing a setof pre-programmed motion commands, including, but not limited to, singleor double tapping the display, dragging a finger or instrument acrossthe display, motioning multiple fingers or instruments toward oneanother, motioning multiple fingers or instruments away from oneanother, etc. In certain embodiments, a display includes a touch screenhaving areas of pixels with single or dual function capacitive elementsthat serve as LCD elements and touch sensors.

Display device 120 also includes data communication port 123 for wireddata communication with external devices such as remote terminal(personal computer) 170, for example. Example embodiments of the datacommunication port 123 include USB port, mini USB port, RS-232 port,Ethernet port, Firewire port, or other similar data communication portsconfigured to connect to the compatible data cables. Display device 120may also include an integrated in vitro glucose meter, including invitro test strip port 124 to receive an in vitro glucose test strip forperforming in vitro blood glucose measurements.

Referring still to FIG. 1B, display 122 in certain embodiments isconfigured to display a variety of information—some or all of which maybe displayed at the same or different time on display 122. In certainembodiments the displayed information is user-selectable so that a usercan customize the information shown on a given display screen. Display122 may include but is not limited to graphical display 138, forexample, providing a graphical output of glucose values over a monitoredtime period (which may show important markers such as meals, exercise,sleep, heart rate, blood pressure, etc., numerical display 132, forexample, providing monitored glucose values (acquired or received inresponse to the request for the information), and trend or directionalarrow display 131 that indicates a rate of analyte change and/or a rateof the rate of analyte change, e.g., by moving locations on display 122.

As further shown in FIG. 1B, display 122 may also include date display135 providing for example, date information for the user, time of dayinformation display 139 providing time of day information to the user,battery level indicator display 133 which graphically shows thecondition of the battery (rechargeable or disposable) of the displaydevice 120, sensor calibration status icon display 134 for example, inmonitoring systems that require periodic, routine or a predeterminednumber of user calibration events, notifying the user that the analytesensor calibration is necessary, audio/vibratory settings icon display136 for displaying the status of the audio/vibratory output or alarmstate, and wireless connectivity status icon display 137 that providesindication of wireless communication connection with other devices suchas on body electronics, data processing module 160, and/or remoteterminal 170. As additionally shown in FIG. 1B, display 122 may furtherinclude simulated touch screen button 125, 126 for accessing menus,changing display graph output configurations or otherwise forcontrolling the operation of display device 120.

Referring back to FIG. 1B, in certain embodiments, display 122 ofdisplay device 120 may be additionally, or instead of visual display,configured to output alarms notifications such as alarm and/or alertnotifications, glucose values etc., which may be audible, tactile, orany combination thereof. In one aspect, the display device 120 mayinclude other output components such as a speaker, vibratory outputcomponent and the like to provide audible and/or vibratory outputindication to the user in addition to the visual output indicationprovided on display 122. Further details and other display embodimentscan be found in, e.g., U.S. patent application Ser. No. 12/871,901, nowU.S. Pat. No. 8,514,086, U.S. Provisional Application Nos. 61/238,672,61/247,541, 61/297,625, the disclosures of each of which areincorporated herein by reference for all purposes.

After the positioning of on body electronics 110 on the skin surface andanalyte sensor 101 in vivo to establish fluid contact with interstitialfluid (or other appropriate body fluid), on body electronics 110 incertain embodiments is configured to wirelessly communicate analyterelated data (such as, for example, data corresponding to monitoredanalyte level and/or monitored temperature data, and/or storedhistorical analyte related data) when on body electronics 110 receives acommand or request signal from display device 120. In certainembodiments, on body electronics 110 may be configured to at leastperiodically broadcast real time data associated with monitored analytelevel which is received by display device 120 when display device 120 iswithin communication range of the data broadcast from on bodyelectronics 110, i.e., it does not need a command or request from adisplay device to send information.

For example, display device 120 may be configured to transmit one ormore commands to on body electronics 110 to initiate data transfer, andin response, on body electronics 110 may be configured to wirelesslytransmit stored analyte related data collected during the monitoringtime period to display device 120. Display device 120 may in turn beconnected to a remote terminal 170 such as a personal computer andfunctions as a data conduit to transfer the stored analyte levelinformation from the on body electronics 110 to remote terminal 170. Incertain embodiments, the received data from the on body electronics 110may be stored (permanently or temporarily) in one or more memory of thedisplay device 120. In certain other embodiments, display device 120 isconfigured as a data conduit to pass the data received from on bodyelectronics 110 to remote terminal 170 that is connected to displaydevice 120.

Referring still to FIG. 1B, also shown in analyte monitoring system 100are data processing module 160 and remote terminal 170. Remote terminal170 may include a personal computer, a server terminal a laptop computeror other suitable data processing devices including software for datamanagement and analysis and communication with the components in theanalyte monitoring system 100. For example, remote terminal 170 may beconnected to a local area network (LAN), a wide area network (WAN), orother data network for uni-directional or bi-directional datacommunication between remote terminal 170 and display device 120 and/ordata processing module 160.

Remote terminal 170 in certain embodiments may include one or morecomputer terminals located at a physician's office or a hospital. Forexample, remote terminal 170 may be located at a location other than thelocation of display device 120. Remote terminal 170 and display device120 could be in different rooms or different buildings. Remote terminal170 and display device 120 could be at least about one mile apart, e.g.,at least about 10 miles apart, e.g., at least about 100 miles apart. Forexample, remote terminal 170 could be in the same city as display device120, remote terminal 170 could be in a different city than displaydevice 120, remote terminal 170 could be in the same state as displaydevice 120, remote terminal 170 could be in a different state thandisplay device 120, remote terminal 170 could be in the same country asdisplay device 120, or remote terminal 170 could be in a differentcountry than display device 120, for example.

In certain embodiments, a separate, optional datacommunication/processing device such as data processing module 160 maybe provided in analyte monitoring system 100. Data processing module 160may include components to communicate using one or more wirelesscommunication protocols such as, for example, but not limited to,infrared (IR) protocol, Bluetooth® protocol, Zigbee® protocol, and802.11 wireless LAN protocol. Additional description of communicationprotocols including those based on Bluetooth® protocol and/or Zigbee®protocol can be found in U.S. Patent Publication No. 2006/0193375incorporated herein by reference for all purposes. Data processingmodule 160 may further include communication ports, drivers orconnectors to establish wired communication with one or more of displaydevice 120, on body electronics 110, or remote terminal 170 including,for example, but not limited to USB connector and/or USB port, Ethernetconnector and/or port, FireWire connector and/or port, or RS-232 portand/or connector.

In certain embodiments, data processing module 160 is programmed totransmit a polling or query signal to on body electronics 110 at apredetermined time interval (e.g., once every minute, once every fiveminutes, or the like), and in response, receive the monitored analytelevel information from on body electronics 110. Data processing module160 stores in its memory the received analyte level information, and/orrelays or retransmits the received information to another device such asdisplay device 120. More specifically in certain embodiments, dataprocessing module 160 may be configured as a data relay device toretransmit or pass through the received analyte level data from on bodyelectronics 110 to display device 120 or a remote terminal (for example,over a data network such as a cellular or WiFi data network) or both.

In certain embodiments, on body electronics 110 and data processingmodule 160 may be positioned on the skin surface of the user within apredetermined distance of each other (for example, about 1-12 inches, orabout 1-10 inches, or about 1-7 inches, or about 1-5 inches) such thatperiodic communication between on body electronics 110 and dataprocessing module 160 is maintained. Alternatively, data processingmodule 160 may be worn on a belt or clothing item of the user, such thatthe desired distance for communication between the on body electronics110 and data processing module 160 for data communication is maintained.In a further aspect, the housing of data processing module 160 may beconfigured to couple to or engage with on body electronics 110 such thatthe two devices are combined or integrated as a single assembly andpositioned on the skin surface. In further embodiments, data processingmodule 160 is detachably engaged or connected to on body electronics 110providing additional modularity such that data processing module 160 maybe optionally removed or reattached as desired.

Referring again to FIG. 1B, in certain embodiments, data processingmodule 160 is programmed to transmit a command or signal to on bodyelectronics 110 at a predetermined time interval such as once everyminute, or once every 5 minutes or once every 30 minutes or any othersuitable or desired programmable time interval to request analyterelated data from on body electronics 110. When data processing module160 receives the requested analyte related data, it stores the receiveddata. In this manner, analyte monitoring system 100 may be configured toreceive the continuously monitored analyte related information at theprogrammed or programmable time interval, which is stored and/ordisplayed to the user. The stored data in data processing module 160 maybe subsequently provided or transmitted to display device 120, remoteterminal 170 or the like for subsequent data analysis such asidentifying frequency of periods of glycemic level excursions over themonitored time period, or the frequency of the alarm event occurrenceduring the monitored time period, for example, to improve therapyrelated decisions. Using this information, the doctor, healthcareprovider or the user may adjust or recommend modification to the diet,daily habits and routines such as exercise, and the like.

In another embodiment, data processing module 160 transmits a command orsignal to on body electronics 110 to receive the analyte related data inresponse to a user activation of a switch provided on data processingmodule 160 or a user initiated command received from display device 120.In further embodiments, data processing module 160 is configured totransmit a command or signal to on body electronics 110 in response toreceiving a user initiated command only after a predetermined timeinterval has elapsed. For example, in certain embodiments, if the userdoes not initiate communication within a programmed time period, suchas, for example about 5 hours from last communication (or 10 hours fromthe last communication, or 24 hours from the last communication), thedata processing module 160 may be programmed to automatically transmit arequest command or signal to on body electronics 110. Alternatively,data processing module 160 may be programmed to activate an alarm tonotify the user that a predetermined time period of time has elapsedsince the last communication between the data processing module 160 andon body electronics 110. In this manner, users or healthcare providersmay program or configure data processing module 160 to provide certaincompliance with analyte monitoring regimen, so that frequentdetermination of analyte levels is maintained or performed by the user.

In certain embodiments, when a programmed or programmable alarmcondition is detected (for example, a detected glucose level monitoredby analyte sensor 101 that is outside a predetermined acceptable rangeindicating a physiological condition which requires attention orintervention for medical treatment or analysis (for example, ahypoglycemic condition, a hyperglycemic condition, an impendinghyperglycemic condition or an impending hypoglycemic condition), the oneor more output indications may be generated by the control logic orprocessor of the on body electronics 110 and output to the user on auser interface of on body electronics 110 so that corrective action maybe timely taken. In addition to or alternatively, if display device 120is within communication range, the output indications or alarm data maybe communicated to display device 120 whose processor, upon detection ofthe alarm data reception, controls the display 122 to output one or morenotification.

In certain embodiments, control logic or microprocessors of on bodyelectronics 110 include software programs to determine future oranticipated analyte levels based on information obtained from analytesensor 101, e.g., the current analyte level, the rate of change of theanalyte level, the acceleration of the analyte level change, and/oranalyte trend information determined based on stored monitored analytedata providing a historical trend or direction of analyte levelfluctuation as function time during monitored time period. Predictivealarm parameters may be programmed or programmable in display device120, or the on body electronics 110, or both, and output to the user inadvance of anticipating the user's analyte level reaching the futurelevel. This provides the user an opportunity to take timely correctiveaction.

Information, such as variation or fluctuation of the monitored analytelevel as a function of time over the monitored time period providinganalyte trend information, for example, may be determined by one or morecontrol logic or microprocessors of display device 120, data processingmodule 160, and/or remote terminal 170, and/or on body electronics 110.Such information may be displayed as, for example, a graph (such as aline graph) to indicate to the user the current and/or historical and/orand predicted future analyte levels as measured and predicted by theanalyte monitoring system 100. Such information may also be displayed asdirectional arrows (for example, see trend or directional arrow display131) or other icon(s), e.g., the position of which on the screenrelative to a reference point indicated whether the analyte level isincreasing or decreasing as well as the acceleration or deceleration ofthe increase or decrease in analyte level. This information may beutilized by the user to determine any necessary corrective actions toensure the analyte level remains within an acceptable and/or clinicallysafe range. Other visual indicators, including colors, flashing, fading,etc., as well as audio indicators including a change in pitch, volume,or tone of an audio output and/or vibratory or other tactile indicatorsmay also be incorporated into the display of trend data as means ofnotifying the user of the current level and/or direction and/or rate ofchange of the monitored analyte level. For example, based on adetermined rate of glucose change, programmed clinically significantglucose threshold levels (e.g., hyperglycemic and/or hypoglycemiclevels), and current analyte level derived by an in vivo analyte sensor,the system 100 may include an algorithm stored on computer readablemedium to determine the time it will take to reach a clinicallysignificant level and will output notification in advance of reachingthe clinically significant level, e.g., 30 minutes before a clinicallysignificant level is anticipated, and/or 20 minutes, and/or 10 minutes,and/or 5 minutes, and/or 3 minutes, and/or 1 minute, and so on, withoutputs increasing in intensity or the like.

Referring again back to FIG. 1B, in certain embodiments, softwarealgorithm(s) for execution by data processing module 160 may be storedin an external memory device such as an SD card, microSD card, compactflash card, XD card, Memory Stick card, Memory Stick Duo card, or USBmemory stick/device including executable programs stored in such devicesfor execution upon connection to the respective one or more of the onbody electronics 110, remote terminal 170 or display device 120. In afurther aspect, software algorithms for execution by data processingmodule 160 may be provided to a communication device such as a mobiletelephone including, for example, WiFi or Internet enabled smart phonesor personal digital assistants (PDAs) as a downloadable application forexecution by the downloading communication device.

Examples of smart phones include Windows®, Android®, iPhone® operatingsystem, Palm® WebOS®, Blackberry® operating system, or Symbian®operating system based mobile telephones with data network connectivityfunctionality for data communication over an internet connection and/ora local area network (LAN). PDAs as described above include, forexample, portable electronic devices including one or moremicroprocessors and data communication capability with a user interface(e.g., display/output unit and/or input unit, and configured forperforming data processing, data upload/download over the internet, forexample. In such embodiments, remote terminal 170 may be configured toprovide the executable application software to the one or more of thecommunication devices described above when communication between theremote terminal 170 and the devices are established.

In still further embodiments, executable software applications may beprovided over-the-air (OTA) as an OTA download such that wiredconnection to remote terminal 170 is not necessary. For example,executable applications may be automatically downloaded as softwaredownload to the communication device, and depending upon theconfiguration of the communication device, installed on the device foruse automatically, or based on user confirmation or acknowledgement onthe communication device to execute the installation of the application.The OTA download and installation of software may include softwareapplications and/or routines that are updates or upgrades to theexisting functions or features of data processing module 160 and/ordisplay device 120.

Referring back to remote terminal 170 of FIG. 1B, in certainembodiments, new software and/or software updates such as softwarepatches or fixes, firmware updates or software driver upgrades, amongothers, for display device 120 and/or on body electronics 110 and/ordata processing module 160 may be provided by remote terminal 170 whencommunication between the remote terminal 170 and display device 120and/or data processing module 160 is established. For example, softwareupgrades, executable programming changes or modification for on bodyelectronics 110 may be received from remote terminal 170 by one or moreof display device 120 or data processing module 160, and thereafter,provided to on body electronics 110 to update its software orprogrammable functions. For example, in certain embodiments, softwarereceived and installed in on body electronics 110 may include softwarebug fixes, modification to the previously stalled software parameters(modification to analyte related data storage time interval, resettingor adjusting time base or information of on body electronics 110,modification to the transmitted data type, data transmission sequence,or data storage time period, among others). Additional detailsdescribing field upgradability of software of portable electronicdevices, and data processing are provided in U.S. patent applicationSer. No. 12/698,124, Ser. No. 12/794,721, now U.S. Pat. No. 8,595,607,Ser. No. 12/699,653, and Ser. No. 12/699,844, and U.S. ProvisionalApplication Nos. 61/359,265, and 61/325,155, the disclosures of whichare incorporated by reference herein for all purposes.

Referring to FIGS. 1A and 1B, an analyte monitoring system 100 cangenerally include, in accordance with one embodiment, an on-body analytemonitoring device, a receiver 120, data processing terminal 170, andsecondary receiver unit 106. Generally, analyte sensor 101 operativelycontacts an analyte to be monitored in a biological fluid, such as, butnot limited to, blood or interstitial fluid, and converts the contactedanalyte level into data signals relating to the amount or concentrationof the analyte. The data signals are communicated to the on bodyelectronics 110, which is in electrical communication with analytesensor 101. The electronics unit can be a separate and distinctcomponent, or can be integrated with the analyte sensor to define asingle component. The on body electronics 110 processes the data signals(e.g., encodes signals) received from analyte sensor 101 and transmitsthe processed data signals to receiver 120, e.g., a primary receiver,along a communication link 103. The communication between on bodyelectronics 110 and receiver 120 can be either unidirectional orbidirectional.

In one aspect of the invention, an interconnect is provided to establishelectrical communication with a transmitter, transceiver, communicationscircuit or other electronics. For example, as illustrated in FIG. 2,on-body electronics unit 110 comprises a body including housing 202. Thehousing includes a top wall connected to a bottom wall by a sidewall. Anelongate interconnect 204 can be coupled to the on body electronics 110.The elongate interconnect 204 comprises conductive material disposed atleast partially along a body having a first end 212 coupled, e.g.,permanently affixed or removably fixed, to housing 202. In oneembodiment, the first end 212 can be secured to a printed circuit board208 disposed in the body of the on body electronics 110. The elongateinterconnect can further include a second end 214 engaged to the on bodyelectronics body, for example, the second end 214 in some embodiments,can be engaged to the housing 202, such as slidingly engaged, forexample at an end opposite the first end 212. Alternatively, the secondend of interconnect 204 may be permanently affixed to the opposite sideof housing 202.

As shown in FIG. 2, a length of the elongate interconnect body 204 canbe configured to extend laterally from a sidewall of the housing 202. Inone embodiment, the elongate interconnect 204 body can include agenerally U-shaped configuration along its length. As such, theinterconnect can be configured to physically contact an analyte sensordisposed proximate the on body electronics body.

In some embodiments, a conductive contact 206 can be located along alength of the elongate interconnect 204. The contact plate is configuredto contact an analyte sensor and establish electrical conductivitybetween the on body electronics and the analyte sensor. (See FIG. 4). Asdescribed, the elongate interconnect comprises conductive material. Inone embodiment, the conductive material defines one or more conductiveareas along the body of the interconnect. The conductive areas caninclude one or more conductive contacts and one or more conductivetraces disposed between conductive contacts along at least a portion ofthe length of the elongate interconnect body. Thus, when in directcontact with the electronic circuitry of the on body electronics and/ora sensor, electrical communications can be established.

For example, referring now to FIG. 3, one embodiment of elongateinterconnect 204 includes the one or more conductive areas defined byconductive material 302, 306, 308. As shown, conductive traces 302extend between conductive contacts 306 and 308. In this manner, theelongate interconnect includes a conductive surface attachable to the onbody electronics, which can establish electrical communication with theon body electronics during contact.

In some embodiments, the conductive material of elongate interconnectincludes conductive traces 302 embedded in a flexible material, such asa flexible strip 304, which generally can be formed from a thermoplasticmaterial. Suitable thermoplastic materials include polyimides such asApical, Kapton, UPILEX, VTEC PI, Norton TH and Kaptrex. In otherembodiments, conductive traces 302 are encapsulated in a flexiblesheath. The elongate interconnect can further include conductive filmsand tapes as described infra.

Suitable elongate interconnects 204 include those depicted in FIGS.5A-5D. As illustrated, the elongate interconnect can comprise conductivematerial including conductive cables, including but not limited to highspeed ribbon cables, microquick twist ribbon cables, microZip cables,mini probe cables, quick twist cables, ribbonized automation cables,shielded flat ribbon cables, or wide pitch ribbon cables, as illustratedin FIGS. 5A to 5D. In addition, other suitable elongate interconnectsinclude All Flex®, Molex®, Tech-Etch®, and Teknoflex®.

The conductive material associated with the interconnect, as well as theon body electronics and/or analyte sensor, can comprise a non-corrodingmetal or carbon wire. Suitable conductive materials include, forexample, vitreous carbon, graphite, silver, silver-chloride, platinum,palladium, or gold. The conductive material disposed on the componentpart, e.g., interconnect, sensor, or on body electronics, can comprise acombination of conductive metals, alloys and polymers. In this regard,for example, the electrodes and the conductive traces and/or conductivecontacts can be formed from different conductive materials. Theconductive material can be applied to the substrate by varioustechniques including laser ablation, printing, etching, andphotolithography. However, any suitable conductive material may beutilized.

Referring back to FIG. 3, conductive contact 306, which is locatedproximate first end 212, can establish electrical communication with theon body electronics 110, for example, the printed circuit board. Theelectrical communication in the form of electrical signals can traveltowards or from the analyte sensor (not shown) via the conductive traces302 and conductive contacts 308. Similarly, conductive area 308, locatedalong a length of elongate member 204, allows conductive traces 302 tobe in electrical communication with conductive contact 206 (not shown)such that a closed circuit is established between the analyte sensor,interconnect and on body electronics.

In one embodiment, on body electronics 110 includes a temperaturesensor. For each sampled signal from analyte sensor 101, the temperaturesensor can provide measured temperature information. In anotherembodiment, on body electronics 110 includes a low-temperature monitorthat disables communication from on body electronics 110 if the measuredtemperature falls below a predefined threshold (e.g., below 5° C.). Thisis done to protect the on body electronics from over-stressing theenergy source of the on body electronics under low-temperatureconditions. If the temperature rises above the predefined threshold, thelow-temperature monitor enables communication from on body electronics110.

In accordance with another aspect of the invention, on body electronics110 includes a low battery voltage monitor that disables the energysource of the on body electronics if the voltage level is too low toreliably transmit communication. The temperature sensor, low-temperaturemonitor, and the low battery voltage monitor may be controlled via aprocessor located in on body electronics 110. In a preferred embodiment,the processor is an application specific integrated circuit (ASIC).

In another aspect, as shown in FIG. 4, an on-body analyte monitoringdevice 100 is provided. The on-body analyte monitoring device includeson body electronics 110 coupled to analyte sensor 402. In oneembodiment, the analyte sensor 402 and on body electronics 110 arehoused in a mounting unit 404. The mounting unit includes adhesiveapplied to the bottom surface to attach the on-body unit to a user.

As illustrated in FIG. 4, elongate interconnect conductive contact 206can be in direct contact with analyte sensor 402 to establish electricalcommunication between the on body electronics 110 and sensor 402. Whenanalyte sensor 402 is in contact with on body electronics 110, elongatemember 204 can be compressed or collapsed and seal 210 forms aprotective barrier around the connection from harmful elements (e.g.,dust, liquid, dirt) between the on body electronics and sensor. In oneembodiment, seal 210 is formed from a flexible polymer.

Seal 210 may be an individual molded component made of a flexiblepolymer, low durometer silicone, rubber or some other material TPE. Insome embodiments, the interconnect extends approximately 1 mm beyond theface of seal 210. When on body electronics 110 is locked into position,elongate interconnect 204 compresses and makes contact with theconductive pads on analyte sensor 402. The seal also compresses to forma barrier around the perimeter of the interconnect/sensor connection.Interconnect 204 may function without the seal, however once liquid ordust got in, the interconnect/sensor interface may be compromised andfail.

In some embodiments, the seal 210 includes an opening to permit directcontact of a conductive contact disposed on the interconnect to theanalyte sensor. In this manner, the analyte sensor and the on bodyelectronics can establish electrical conductivity via the closed circuitprovided by the interconnect.

In another embodiment, the elongate member 204 returns to its originalconfiguration after analyte sensor 402 is disengaged from on bodyelectronics 110. The signals generated by the analyte sensor relating tothe measured analyte levels from biological fluid can be processed bythe on body electronics 110 by the electrical contact between sensor 402and on body electronics via contact plate 206 of interconnect.

The analyte sensor 402 employed in the on-body device, in someembodiments, comprises a substrate, one or more electrodes, a sensinglayer and a barrier layer, as described below and disclosed in U.S. Pat.Nos. 6,284,478 and 6,990,366, the disclosures of which are incorporatedherein by reference. As the sensor is employed by insertion and/orimplantation into a user's body for a period of days, in someembodiments, the substrate is formed from a relatively flexible materialto improve comfort for the user and reduce damage to the surroundingtissue of the insertion site, e.g., by reducing relative movement of thesensor with respect to the surrounding tissue.

Suitable materials for a flexible substrate include, for example,non-conducting plastic or polymeric materials and other non-conducting,flexible, deformable materials. Suitable plastic or polymeric materialsinclude thermoplastics such as polycarbonates, polyesters (e.g., Mylar®and polyethylene terephthalate (PET)), polyvinyl chloride (PVC),polyurethanes, polyethers, polyamides, polyimides, or copolymers ofthese thermoplastics, such as PETG (glycol-modified polyethyleneterephthalate). In other embodiments, the sensor includes a relativelyrigid substrate. Suitable examples of rigid materials that may be usedto form the substrate include poorly conducting ceramics, such asaluminum oxide and silicon dioxide. Further, the substrate can be formedfrom an insulating material. Suitable insulating materials includepolyurethane, teflon (fluorinated polymers), polyethyleneterephthalate(PET, Dacron) or polyimide.

The sensor can include a distal end and a proximal end having differentwidths. In such embodiments, the distal end of the substrate may have arelatively narrow width. Moreover, sensors intended to betranscutaneously positioned into the tissue of a user's body can beconfigured to have a narrow distal end or distal point to facilitate theinsertion of the sensor. For example, for insertable sensors designedfor continuous or periodic monitoring of the analyte during normalactivities of the patient, a distal end of the sensor which is to beimplanted into the user has a width of 2 mm or less, preferably 1 mm orless, and more preferably 0.5 mm or less.

A plurality of electrodes is disposed near the distal end of the sensor.The electrodes can include a working electrode, counter electrode andreference electrode. Other embodiments, however, can include less ormore electrodes. For example, as noted, a two electrode sensor can beutilized. Each of the electrodes is formed from conductive material, forexample, a non-corroding metal or carbon wire. Suitable conductivematerials include, for example, vitreous carbon, graphite, silver,silver-chloride, platinum, palladium, or gold. The conductive materialcan be applied to the substrate by various techniques including laserablation, printing, etching, and photolithography. In one embodiment,each of the electrodes is formed from gold by a laser ablationtechnique. As further illustrated, the sensor can include conductivetraces and extending from the one or more electrodes to respectivecontacts. In one embodiment, an insulating substrate (e.g., dielectricmaterial) and electrodes can be arranged in a stacked orientation (i.e.,insulating substrate disposed between electrodes. Alternatively, theelectrodes can be arranged in a side by side orientation, as describedin U.S. Pat. No. 6,175,752, the disclosure of which is incorporatedherein by reference.

The sensor can include a sensing layer to facilitate the electrolysis ofthe analyte of interest. For example, the sensing layer can be animmobilized sensing layer comprising a catalyst and an electron transferagent. Examples of immobilized sensing layers are described in U.S. Pat.Nos. 5,262,035, 5,264,104, 5,264,105, 5,320,725, 5,593,852, and5,665,222, each of which is incorporated herein by reference. In someembodiments, the sensor can further include a barrier layer to act as adiffusion-limiting barrier to reduce the rate of mass transport of theanalyte into the region around the working electrode. Examples ofsuitable barrier layers are described in U.S. Pat. Nos. 6,990,366 and6,175,752, each of which is incorporated herein by reference.

In some embodiments, the sensor is a self-powered analyte sensor, whichis capable of spontaneously passing a currently directly proportional toanalyte concentration in the absence of an external power source. Anyexemplary sensor is described in U.S. patent application Ser. No.12/393,921, filed Feb. 26, 2009, entitled “Self-Powered Analyte Sensor,”which is hereby incorporated by reference in its entirety herein for allpurposes.

FIGS. 6, 7A-7B, and 8 illustrate on body electronics including a moduleinterconnect in certain embodiments, with FIGS. 8 and 7A illustrate topperspective views, while FIGS. 7B and 8 illustrating bottom perspectiveviews. Referring to FIGS. 6 and 7A, on body electronics 600 includesmodular sensor assembly 604 which includes analyte sensor 710 (see e.g.,FIG. 7B), for engageably coupling with electronics component 604. Asillustrated, the modular sensor assembly 602 may be configured tointerlock or otherwise engage with the electronics component 604.Accordingly, upon engagement of modular sensor assembly 602 andelectronics component 604, on body electronics 600 with analyte sensor710 may be provided.

In certain embodiments, modular sensor assembly 602 may be a moldeddevice, such as for example, formed by injection molding techniques. Asillustrated in FIG. 7A, modular sensor assembly 602 includes bottomsurface 701 connected to top surface 702 by sidewall 703. As can be seenin the perspective views of FIGS. 7B and 8, in certain embodiments, topsurface 702 includes conductive material 714 disposed thereon. Further,top surface 702 may include a vertical surface extending downwardly,which may include conductive material 716 disposed thereon. In certainembodiments, conductive material 716 includes conductive traces and/orconductive contacts.

Still referring to the figures, on body electronics 600 in certainembodiments include modular sensor assembly 602 and electronicscomponent 604 configured for a slidable engagement. As illustrated inFIG. 7A, the bottom of electronics component 604 may include a surfaceconfigured to slidably receive modular sensor assembly 602. Further, incertain embodiments, top surface 702 of modular sensor assembly 602 maybe configured to define a tongue to interlock with a correspondinggroove 704 defined in electronics component 604 to define the shape ofon body electronics 600.

Electronics component 604 in certain embodiments may include one or morePCBs including conductive material 708 disposed thereon, such as one ormore conductive traces and/or conductive contacts. During engagement ofelectronics component 604 with modular sensor assembly 602, theconductive material 708 can interface with interconnect conductivematerial 714. Thus, during engagement, the electronics component 604 andmodular sensor assembly 602 establishes electrical communication.

As illustrated in FIG. 7B, modular sensor assembly 602 includes analytesensor 710 secured or otherwise coupled to a surface of the modularsensor assembly 602. For example, analyte sensor 710 may be coupled tothe vertical surface extending from the top surface of the modularsensor assembly 602. In this manner, the vertical surface includesconductive material, such as conductive contacts 804 that connect withthe one or more conductive contacts of analyte sensor 710 to establishan electrical communication between analyte sensor 710 and modularsensor assembly 602.

In certain embodiments, as best illustrated in FIGS. 7B and 8, analytesensor 710 may be mounted to the sidewall of modular sensor assembly602. In this embodiment, distal portion 710 a of analyte sensor 710 isinserted perpendicular to the skin (not shown). In this regard, thebottom surface of the modular sensor assembly 602 includes an aperture720 (FIGS. 7B) to permit the distal portion 710 a of analyte sensor 710to extend from the bottom of on body electronics 600 such that distalportion 710 a of analyte sensor 710 may be implanted into the body of auser when in use. In certain embodiments, modular sensor assembly 602may also include a power source 712, such as a battery. Power source 712may provide power via conductive traces 714 to the electronics component604. In this manner, the electronics component 604 may be powered bypower source 712 of modular sensor assembly 602 such that theelectronics component 604 does not need an internal power source.

The conductive material disposed on the modular sensor assembly 602and/or the electronics component 604 and analyte sensor 710 may includeconductive film, such as, but not limited to, an anisotropic film.Conductive material, such as the conductive film and/or the Zebra styleconnector, can provide both a mechanical and electrical connectionbetween modular sensor assembly 602 and sensor 710 or electronicscomponent 604. Modular sensor assembly 602, analyte sensor 710, andelectronics component 604 may also be bonded together utilizing anadhesive, such as a UV curable adhesive, or a multi-adhesive, such as asilver loaded epoxy can be used. Other adhesives can alternatively beemployed.

The sensor and the on body electronics can establish electricalcommunication by way of the interconnect. In this manner, the one ormore electrodes of the analyte sensor generate a signal relative to theanalyte levels depicted in the bodily fluid of the user, the conductivetraces permit the signal to travel to the conductive contacts of thesensor which is in electrical communication with the conductivematerial, e.g., conductive contacts 804 of the interconnect. By way ofthe conductive traces 716 and 802, which establish electricalcommunication with the on body electronics 600, the signals relative tothe analyte levels are communicated to the on body electronics 600. Thebottom surface of the on body electronics 600 and/or modular sensorassembly 602 can include an adhesive to attach to the skin of the user.Thus, the interconnect can serve as a mounting unit for the on-bodymonitoring device to be worn by a user. The on-body analyte monitoringdevice, as described above, can be employed as a component of an analytemonitoring system, such as the systems illustrated in FIGS. 1A and 1B.

On body electronics 600 may be mounted to the user as one component orseparately. For example, with reference to FIG. 7A, the modular sensorassembly 602 may be first mounted on the skin such that the distalportion 710 a (not shown) of the sensor 710 is at least partiallyinserted into the skin. An adhesive (not shown) is used to fix modularsensor assembly 602 to the skin. Subsequently, the electronics component604 may be attached to modular sensor assembly 602, for example, bysliding the electronics component 604 in the direction of arrow 7A, suchthat the modular sensor assembly 602 and electronics component 604 aresecured together. In some embodiments, the electronics component 604 ismounted first and the modular sensor assembly 602 is mountedsubsequently.

In some embodiments, the modular sensor assembly 602 and electronicscomponent 604 are secured together, and then subsequently mounted ontothe patient as a single unit 600. Insertion of electronics unit 600 byan inserter, such as inserter 150 (FIG. 1B) is further described as aninsertion device, e.g., as described in U.S. patent application Ser. No.12/698,129 filed on Feb. 1, 2010 and U.S. Provisional Application Nos.61/238,646, 61/246,825, 61/247,516, 61/249,535, 61/317,243, 61/345,562,and 61/361,374, the disclosures of each of which are incorporated hereinby reference for all purposes.

In some embodiments, the analyte monitoring system 100 can include asecondary receiver unit 106 which is operatively coupled to thecommunication link and configured to receive data transmitted from theon body electronics 110. Moreover, the secondary receiver unit 106 canbe configured to communicate with the display unit 120 as well as a dataprocessing terminal 170. The secondary receiver unit 106 may beconfigured for bi-directional wireless communication with each or one ofthe display unit 104 and the data processing terminal 170.

In one embodiment, the secondary receiver unit 106 may be configured toinclude a limited number of functions and features as compared with thedisplay unit 104. As such, the secondary receiver unit 106 may beconfigured substantially in a smaller compact housing or embodied in adevice such as a wrist watch, pager, mobile phone, PDA, for example.Alternatively, the secondary receiver 106 may be configured with thesame or substantially similar functionality as the display unit 104. Thereceiver unit may be configured to be used in conjunction with a dockingcradle unit, for example for one or more of the following or otherfunctions: placement by bedside, for re-charging, for data management,for night time monitoring, and/or bi-directional communication device.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims. Additional detailed description of embodiments of the disclosedsubject matter are provided in, but not limited to: U.S. Pat. Nos.7,299,082; 7,167,818; 7,041,468; 6,942,518; 6,893,545; 6,881,551;6,773,671; 6,764,581; 6,749,740; 6,746,582; 6,736,957; 6,730,200;6,676,816; 6,618,934; 6,616,819; 6,600,997; 6,592,745; 6,591,125;6,560,471; 6,540,891; 6,514,718; 6,514,460; 6,503,381; 6,461,496;6,377,894; 6,338,790; 6,299,757; 6,284,478; 6,270,455; 6,175,752;6,161,095; 6,144,837; 6,143,164; 6,121,009; 6,120,676; 6,071,391;5,918,603; 5,899,855; 5,822,715; 5,820,551; 5,628,890; 5,601,435;5,593,852; 5,509,410; 5,320,715; 5,264,014; 5,262,305; 5,262,035;4,711,245; 4,545,382; 5,356,786; 5,543,326; 6,103,033; 6,134,461;6,143,164; 6,144,837; 6,161,095; 6,579,690; 6,605,200; 6,605,201;6,618,934; 6,654,625; 6,676,816; 6,730,200; 6,736,957; 6,932,892; U.S.Publication No. 2004/0186365, now U.S. Pat. No. 7,811,231; U.S.Publication No. 2005/0182306, now U.S. Pat. No. 8,771,183; U.S.Publication No. 2006/0025662, now U.S. Pat. No. 7,740,581; U.S.Publication No. 2006/0091006; U.S. Publication No. 2007/0056858, nowU.S. Pat. No. 8,298,389; U.S. Publication No. 2007/0068807, now U.S.Pat. No. 7,846,311; U.S. Publication No. 2007/0095661; U.S. PublicationNo. 2007/0108048, now U.S. Pat. No. 7,918,975; U.S. Publication No.2007/0199818, now U.S. Pat. No. 7,811,430; U.S. Publication No.2007/0227911, now U.S. Pat. No. 7,887,682 ; U.S. Publication No.2007/0233013; U.S. Publication No. 2008/0066305, now U.S. Pat. No.7,895,740; U.S. Publication No. 2008/0081977, now U.S. Pat. No.7,618,369; U.S. Publication No. 2008/0102441, now U.S. Pat. No.7,822,557; U.S. Publication No. 2008/0148873, now U.S. Pat. No.7,802,467; U.S. Publication No. 2008/0161666; U.S. Publication No.2008/0267823; U.S. Publication No. 2009/0054748, now U.S. Pat. No.7,885,698; U.S. patent application Ser. No. 10/745,878, filed Dec. 26,2003, now U.S. Pat. No. 7,811,231, and entitled “Continuous GlucoseMonitoring System and Methods of Use”, U.S. patent application Ser. No.12/143,731, filed Jun. 20, 2008, now U.S. Pat. No. 8,597,188, andentitled “Health Management Devices And Methods”; U.S. patentapplication Ser. No. 12/143,734, filed Jun. 20, 2008, now U.S. Pat. No.8,617,069, and entitled “Health Monitor”; U.S. Provisional PatentApplication No. 61/149,639, filed Feb. 3, 2009, and entitled “CompactOn-Body Physiological Monitoring Devices And Methods Thereof”; U.S.Provisional Application No. 61/291,326, filed Dec. 30, 2009, and U.S.Provisional Application No. 61/299,924 filed Jan. 29, 2010; U.S. patentapplication Ser. No. 11/461,725, now U.S. Pat. No. 7,866,026; U.S.patent application Ser. No. 12/131,012; U.S. patent application Ser. No.12/242,823, now U.S. Pat. No. 8,219,173; U.S. patent application Ser.No. 12/363,712, now U.S. Pat. No. 8,346,335; U.S. patent applicationSer. No. 12/698,124; U.S. patent application Ser. No. 12/698,129; U.S.patent application Ser. No. 12/714,439; U.S. patent application Ser. No.12/794,721, now U.S. Pat. No. 8,595,607; U.S. patent application Ser.No. 12/842,013; U.S. Patent Application No. 61/238,646; U.S. PatentApplication No. 61/345,562; U.S. Patent Application No. 61/361,374; andelsewhere, the disclosures of each are incorporated by reference intheir entirety herein for all purposes.

1. An electronics unit for receiving one or more signals from an analytesensor, the electronics unit comprising: a body having a top surface, anopposing bottom surface and a sidewall defined therebetween, a processorand a circuit board disposed within the body of the electronics unit,and an elongate interconnect comprising conductive material defining abody of the interconnect, the body having a first end secured to thecircuit board and a second end engaged to the body of the electronicsunit, and a length extending laterally from the sidewall of the body ofthe electronics unit.
 2. The electronics unit of claim 1, wherein theprocessor is an application specific integrated circuit (ASIC).
 3. Theelectronics unit of claim 1, wherein the conductive material defines aconductive area.
 4. The electronics unit of claim 3, wherein theconductive area contacts the circuit board disposed in the body of theelectronics unit.
 5. The electronics unit of claim 4, wherein theconductive area establishes electrical communication between theelongate interconnect and the circuit board.
 6. The electronics unit ofclaim 1, wherein the elongate interconnect further comprises a contactplate disposed along a length of the interconnect body. configured tocontact or engage the analyte sensor, and further wherein such contactestablishes electrical communication between the interconnect and theanalyte sensor.
 8. The electronics unit of claim 1, wherein the elongateinterconnect is substantially U-shaped.
 9. The electronics unit of claim1, wherein the elongate interconnect comprises material sufficientlyflexible to collapse upon engagement with an analyte sensor.
 10. Theelectronics unit of claim 1, wherein the conductive material comprisesgold.
 11. The electronics unit of claim 1, wherein the conductivematerial defines conductive traces, and further wherein the conductivetraces are embedded in flexible material.
 12. The electronics unit ofclaim 11, wherein the flexible material is formed from a thermoplasticmaterial.
 13. The electronics unit of claim 12, wherein thethermoplastic material includes polyimide.
 14. The electronics unit ofclaim 13, wherein the polyimide is Kapton®.
 15. The electronics unit ofclaim 1, wherein the conductive material includes a plurality ofconductive cables, and further wherein the plurality of conductivecables is encapsulated within a flexible sheath.
 16. The electronicsunit of claim 1, wherein the conductive material includes ribbon cables.17. The electronics unit of claim 16, wherein the ribbon cables areembedded in a flexible material.
 18. An on-body analyte monitoringdevice comprising: a mounting unit having a bottom surface adapted toattach to skin of a subject; an analyte sensor configured to detect andmonitor an analyte, the analyte sensor being disposed in the mountingunit; an electronics unit for receiving one or more signals from theanalyte sensor, the electronics unit comprising a body having a topsurface, and opposing bottom surface and a sidewall definedtherebetween, a processor and a PCB disposed within the body of theelectronics unit; and an elongate interconnect comprising conductivematerial defining a body of the interconnect, the body having a firstend secured to the circuit board and a second end engaged to the body ofthe electronics unit, and a length extending laterally from the sidewallof the body of the electronics unit, wherein at least a section of thelength directly contact the analyte sensor.
 19. The on-body analytemonitoring device of claim 18, wherein the analyte sensor comprises oneor more electrodes.
 20. The on-body analyte monitoring device of claim19, wherein the electrodes comprise gold. 21-101. (canceled)